BIOINVEST BREAKING NEWS – WVE has announced new data from the Phase 1 portion of its first-in-human INLIGHT trial evaluating WVE-007 in otherwise healthy individuals living with overweight or obesity. After six months of follow-up, a single 240 mg dose led to further improvements in body composition, (…more)
BIOINVEST BREAKING NEWS – VKTX reported yesterday that a productive end of Phase II meeting with the FDA will allow the company to advance ‘2735 oral directly into Phase III development without another Phase II. (…more)
BIOINVEST BREAKING NEWS – Ionis (IONS) had great news today when they reported positive topline data from the Phase III CORE (n=617) and CORE2 (n=446) trials of Olezarsen in severe hypertriglyceridemia (sHTG), where there was a statistically significant placebo-adjusted mean reduction (…more)
BIOINVEST BREAKING NEWS – Precigen has received FDA approval for PAPZIMEOS for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP. In a major positive for the Company, the approval came early as the FDA PDUFA date was Aug. 27. (…more)
BIOINVEST BREAKING NEWS – PGEN reported excellent Papzimeos Q4 revenue with an even better projection for $18 million in Q1. The company reported strong revenue growth, with Q4 2025 net product revenue at $3.4 million and expected Q1 2026 revenue to exceed $18 million. (…more)
BIOINVEST BREAKING NEWS – Skye (SKYE) – On a negative note, Nimacimab’s Phase II study missed its primary endpoint, with a much lower/negligible effect on weight loss at Week 26 (-1.26%, n.s.) than expected. The monotherapy trial failure was attributed to (…more)
BIOINVEST BREAKING NEWS – Celldex (CLDX) — The Phase II study with barzolvolimab for eosinophilic esophagitis (EoE) met the primary endpoint of a statistically significant drop in mucosal mast cells (MC). However, the strong MC efficacy did not translate into a clinical benefit. (…more)
BIOINVEST BREAKING NEWS – Celldex (CLDX) — Celldex delivered another unprecedented clinical update for barzolvolimab (“barzo”) in CSU, further cementing the antibody’s position as the leading compound to change clinical practice in this disease of suffering. (…more)
BIOINVEST BREAKING NEWS – Celldex (CLDX) — The Barzo Train Has Left The Station – Phase III Trials Enroll Well Ahead Of Schedule — This morning, CLDX announced that the two Phase III trials for barzovolimab (“barzo”) in chronic spontaneous urticaria (CSU) have completed enrollment six months ahead of schedule. (…more)
BIOINVEST BREAKING NEWS – Viking (VKTX) – On a positive note, MTSR’s preliminary merger proxy statement released today and stated there were up to seven interested parties and three companies with bids offered, including PFE. (…more)
BIOINVEST BREAKING NEWS – Viking (VKTX) – VKTX reported topline data from Phase II VENTURE-Oral VK2735 this morning with strong dose-dependent efficacy but a slightly higher GI side effect profile (albeit a higher placebo GI rate, too). We believe the compound’s competitiveness (…more)
BIOINVEST BREAKING NEWS – Viking (VKTX) – Yesterday VKTX has checked off another important box in its obesity drug competitiveness by securing production capacity for their second generation GLP drug, VK2735. The Company will prepay leading global contract manufacturer CordenPharma (…more)
